3D-printed biodressing functions during multiple phases of treatment for chronic wounds and severe burns

In Brazil, there is still no advanced therapy product for the treatment of chronic wounds and burns that has been registered with health regulatory bodies. A startup based at the Supera Innovation and Technology Park in Ribeirão Preto, in the interior of the state of São Paulo, intends to break down this barrier and become a pioneer in this segment.

The company has developed a 3D-printed biodressing containing human umbilical cord stem cells for the treatment of patients with chronic wounds and severe burns.

In Situ will present its technology at the University of São Paulo (USP) stand at the international VivaTech fair, one of Europe’s largest startup and technology events, which takes place June 11–14 in Paris, France.

“Participating in VivaTech represents an excellent opportunity for us to understand how the market for advanced therapy products works in Europe, where there are already some registered products,” Adriana Manfiolli, a researcher and partner in the company, told Agência FAPESP.

Named Mensencure, the biodressing is made with hydrogel and contains mesenchymal cells, which secrete numerous bioactive molecules with different functions in the healing process, such as cytokines and growth factors responsible for immunomodulation, angiogenesis (the creation of new blood vessels) and improving the quality of scar tissue.

The 3D biodressing is considered smart because it contains living cells that can perceive the signals emitted by skin injuries and respond by releasing cytokines and growth factors according to the tissue’s needs. Unlike most conventional products, which only aim to cover the lesion or treat a specific phase of healing, Mensencure acts in the different phases of skin healing.

Skin lesions in diabetics

One of the product’s applications is the treatment of skin lesions in people with type 1 diabetes, who have difficulty healing their skin. When the disease is not well controlled, an excess of sugar in the bloodstream hinders various stages of healing and prevents tissue regeneration.

“We know that the skin is a fabulous tissue that heals naturally, but there are people with underlying pathologies, such as diabetes, in whom this process is impaired. The biodressing is intended precisely for these patients with impaired healing, whose wounds don’t close or sometimes take months or even years to heal,” says Oliveira.

However, the company intends to use the biodressing initially to treat patients with pressure injuries, popularly known as bedsores. Clinical trials are still needed, though. If the results are positive, the company can request approval for the product from the National Health Surveillance Agency (ANVISA), the federal agency that regulates health treatments, technologies, and procedures in Brazil.

“We’re in the midst of this critical period, working on the production of both the cells and the dressing in accordance with Good Manufacturing Practices [GMP] in order to obtain authorization from ANVISA to carry out a clinical study,” says Oliveira.

The researchers’ goal is to produce the biodressing and other products based on the technology in the company’s laboratory. “Unlike most biotechs, we want to go to market,” she says.